pramipexole: package leaflet

For patients

Package leaflet, verbatim

Mirapexin

Package leaflet: MIRAPEXIN 0.088 mg tablets / MIRAPEXIN 0.18 mg tablets / MIRAPEXIN 0.35 mg tablets / MIRAPEXIN 0.7 mg tablets

1. What MIRAPEXIN is and what it is used for

MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.

MIRAPEXIN is used to:
- treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).
- treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.

2. What you need to know before you take MIRAPEXIN

Do not take MIRAPEXIN
- if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking MIRAPEXIN. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
- Kidney disease
- Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up-titration of MIRAPEXIN.
- Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).

Sleepiness and episodes of suddenly falling asleep
Psychosis (e.g. comparable with symptoms of schizophrenia)
Vision impairment. You should have regular eye examinations during treatment with MIRAPEXIN.
Severe heart or blood vessels disease. You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in blood pressure on standing up).
Restless legs augmentation syndrome. If you experience that symptoms start earlier than usual in the evening (or even the afternoon), are more intense or involve larger parts of the affected limbs or involve other limbs. Your doctor may lower your dose or stop the treatment.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your MIRAPEXIN treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you are developing an inability of keeping your body and neck straight and upright (axial dystonia). If this happens, your doctor may want to adjust or change your medication.

Children and adolescents
MIRAPEXIN is not recommended for use in children or adolescents under 18 years.

Other medicines and MIRAPEXIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking MIRAPEXIN together with antipsychotic medicines.

Take care if you are taking the following medicines:
- cimetidine (to treat excess stomach acid and stomach ulcers)
- amantadine (which can be used to treat Parkinson’s disease)
- mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
- zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
- cisplatin (to treat various types of cancers)
- quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
- procainamide (to treat irregular heart beat)

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with MIRAPEXIN.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases MIRAPEXIN may affect your ability to drive and operate machinery.

MIRAPEXIN with food, drink and alcohol
You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
MIRAPEXIN can be taken with or without food.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take MIRAPEXIN.

The effect of MIRAPEXIN on the unborn child is not known. Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to do so.

MIRAPEXIN should not be used during breast-feeding. MIRAPEXIN can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of MIRAPEXIN is unavoidable, breast-feeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
MIRAPEXIN can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

3. How to take MIRAPEXIN

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The doctor will advise you on the right dosing.

You can take MIRAPEXIN with or without food. Swallow the tablets with water.

Parkinson’s disease
The daily dose is to be taken divided into 3 equal doses.

During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg three times a day (equivalent to 0.264 mg daily):

1st week
Number of tablets
1 tablet MIRAPEXIN 0.088 mg three times a day
Total daily dose (mg)
0.264

This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

2nd week
3rd week
Number of tablets
1 tablet MIRAPEXIN 0.18 mg three times a day
OR
2 tablets MIRAPEXIN 0.088 mg three times a day
1 tablet MIRAPEXIN 0.35 mg three times a day
OR
2 tablets MIRAPEXIN 0.18 mg three times a day
Total daily dose (mg)
0.54
1.1

The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of

pramipexole a day. A lower maintenance dose of three MIRAPEXIN 0.088 mg tablets a day is also possible.

Lowest maintenance dose
Highest maintenance dose
Number of tablets
1 tablet MIRAPEXIN 0.088 mg three times a day
1 tablet MIRAPEXIN 0.7 mg and
1 tablet MIRAPEXIN 0.35 mg three times a day
Total daily dose (mg)
0.264
3.15

Patients with kidney disease
If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet MIRAPEXIN 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet MIRAPEXIN 0.088 mg a day.

Restless Legs Syndrome
The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.

During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):

1st week
Number of tablets
1 tablet MIRAPEXIN 0.088 mg
Total daily dose (mg)
0.088

This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

2nd week
3rd week
4th week
Number of tablets
1 tablet MIRAPEXIN
0.18 mg
OR
2 tablets MIRAPEXIN
0.088 mg
1 tablet MIRAPEXIN
0.35 mg
OR
2 tablets MIRAPEXIN
0.18 mg
OR
4 tablets MIRAPEXIN
0.088 mg
1 tablet MIRAPEXIN
0.35 mg and 1 tablet
MIRAPEXIN 0.18 mg
OR
3 tablets MIRAPEXIN
0.18 mg
OR
6 tablets MIRAPEXIN
0.088 mg
Total daily dose (mg)
0.18
0.35
0.54

The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).

If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose. You can then build up the dose again, as you did the first time. Ask your doctor for advice.

Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.

Patients with kidney disease
If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.

If you take more MIRAPEXIN than you should
If you accidentally take too many tablets,
- Contact your doctor or nearest hospital casualty department immediately for advice.

You may experience vomiting, restlessness, or any of the side effects as described in section 4 “Possible side effects”.

If you forget to take MIRAPEXIN
Do not worry. Simply leave out that dose completely and then take your next dose at the right time.
Do not try to make up for the missed dose.

If you stop taking MIRAPEXIN
Do not stop taking MIRAPEXIN without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with MIRAPEXIN abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:
- akinesia (loss of muscle movement)
- rigid muscles
- fever
- unstable blood pressure
- tachycardia (increased heart rate)
- confusion
- depressed level of consciousness (e.g. coma)

If you stop or reduce MIRAPEXIN you may also develop a medical condition called dopamine agonist withdrawal syndrome. The symptoms include depression, apathy, anxiety, fatigue, sweating or pain. If you experience these symptoms you should contact your physician.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Evaluation of these side effects is based on the following frequencies:

Very common may affect more than 1 in 10 people
Common may affect up to 1 in 10 people
Uncommon may affect up to 1 in 100 people
Rare may affect up to 1 in 1 000 people
Very rare may affect up to 1 in 10 000 people
Not known
Frequency cannot be estimated from the available data

If you suffer from Parkinson’s disease, you may experience the following side effects:

Very common:
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
- Sleepiness
- Dizziness
- Nausea (sickness)

Hypotension (low blood pressure)
Abnormal dreams
Constipation
Visual impairment
Vomiting (being sick)
Weight loss including decreased appetite

Uncommon:
- Paranoia (e.g. excessive fear for one’s own well-being)
- Delusion
- Excessive daytime sleepiness and suddenly falling asleep
- Amnesia (memory disturbance)
- Hyperkinesia (increased movements and inability to keep still)
- Weight increase
- Allergic reactions (e.g. rash, itching, hypersensitivity)
- Fainting
- Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
- Inappropriate antidiuretic hormone secretion*
- Restlessness
- Dyspnoea (difficulties to breathe)
- Hiccups
- Pneumonia (infection of the lungs)
- Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- Strong impulse to gamble excessively despite serious personal or family consequences.
- Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
- Uncontrollable excessive shopping or spending
- Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
- Delirium (decreased awareness, confusion, loss of reality)

Rare:
- Mania (agitation, feeling elated or over-excited)
- Spontanoeus penile erection

Not known:
- After stopping or reducing your MIRAPEXIN treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2 762 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.

If you suffer from Restless Legs Syndrome, you may experience the following side effects:

Very common:
- Nausea (sickness)
- Symptoms that start earlier than usual, are more intense or involve other limbs (Restless legs augmentation syndrome).

Common:
- Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
- Tiredness (fatigue)

Headache
Abnormal dreams
Constipation
Dizziness
Vomiting (being sick)

Uncommon:
- Urge to behave in an unusual way*
- Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
- Inappropriate antidiuretic hormone secretion*
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
- Hyperkinesia (increased movements and inability to keep still)*
- Paranoia (e.g. excessive fear for one’s own well-being)*
- Delusion*
- Amnesia (memory disturbance)*
- Hallucinations (seeing, hearing or feeling things that are not there)
- Confusion
- Excessive daytime sleepiness and suddenly falling asleep
- Weight increase
- Hypotension (low blood pressure)
- Excess of fluid, usually in the legs (peripheral oedema)
- Allergic reactions (e.g. rash, itching, hypersensitivity)
- Fainting
- Restlessness
- Visual impairment
- Weight loss including decreased appetite
- Dyspnoea (difficulties to breathe)
- Hiccups
- Pneumonia (infection of the lungs)*
- Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- Strong impulse to gamble excessively despite serious personal or family consequences.*
- Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.*
- Uncontrollable excessive shopping or spending*
- Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
- Mania (agitation, feeling elated or over-excited)*
- Delirium (decreased awareness, confusion, loss of reality)*

Rare:
- Spontanoeus penile erection

Not known:
- After stopping or reducing your MIRAPEXIN treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1 395 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.

listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store MIRAPEXIN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C.
Store in the original package to protect the tablets from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What MIRAPEXIN contains

The active substance is pramipexole.

Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, or 0.7 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively.

The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.

What MIRAPEXIN looks like and contents of the pack
MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.

MIRAPEXIN 0.18 mg tablets and MIRAPEXIN 0.35 mg tablets are white, of oval shape, and flat.
Tablets are scored on both sides and breakable in halves.

MIRAPEXIN 0.7 mg tablets are white, of round shape, and flat. Tablets are scored on both sides and breakable in halves.

All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg, respectively.

All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Rottendorf Pharma GmbH
Ostenfelder Strasse 51 – 61
59320 Ennigerloh
Germany

Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ – клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf.: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
BIOTHERAX biochemisch-pharmazeutische
Gesellschaft mbH
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Danmark A/S NUF
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Tηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp.zo.o.
Tel: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Tηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Package leaflet: MIRAPEXIN 0.26 mg prolonged-release tablets / MIRAPEXIN 0.52 mg prolonged-release tablets / MIRAPEXIN 1.05 mg prolonged-release tablets / MIRAPEXIN 1.57 mg prolonged-release tablets / MIRAPEXIN 2.1 mg prolonged-release tablets / MIRAPEXIN 2.62 mg prolonged-release tablets

1. 0.26

One MIRAPEXIN 0.26 mg prolonged-release tablet.

2. 0.52

One MIRAPEXIN 0.52 mg prolonged-release tablet,
OR two MIRAPEXIN 0.26 mg prolonged-release tablets.

3. 1.05

One MIRAPEXIN 1.05 mg prolonged-release tablet,
OR two MIRAPEXIN 0.52 mg prolonged-release tablets,
OR four MIRAPEXIN 0.26 mg prolonged-release tablets.

The usual maintenance dose is 1.05 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your dose up to a maximum of 3.15 mg of pramipexole a day. A lower maintenance dose of one MIRAPEXIN 0.26 mg prolonged-release tablet a day is also possible.

Patients with kidney disease
If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets only every other day for the first week. After that, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet every day. If a further dose increase is necessary, your doctor may adjust it in steps of 0.26 mg pramipexole.

If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine. If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.

If you are switching from MIRAPEXIN (immediate release) tablets
Your doctor will base your dose of MIRAPEXIN prolonged-release tablets on the dose of MIRAPEXIN (immediate release) tablets you were taking.

Take your MIRAPEXIN (immediate release) tablets as normal the day before you switch. Then take your MIRAPEXIN prolonged-release tablets next morning and do not take any more MIRAPEXIN (immediate release) tablets.

If you take more MIRAPEXIN than you should
If you accidentally take too many tablets,
- Contact your doctor or nearest hospital casualty department immediately for advice.
- You may experience vomiting, restlessness, or any of the side effects as described in section 4 “Possible side effects”.

If you forget to take MIRAPEXIN
If you forget to take a dose of MIRAPEXIN, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.

unstable blood pressure
tachycardia (increased heart rate)
confusion
depressed level of consciousness (e.g. coma)

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Evaluation of these side effects is based on the following frequencies:

Very common may affect more than 1 in 10 people
Common may affect up to 1 in 10 people
Uncommon may affect up to 1 in 100 people
Rare may affect up to1 in 1 000 people
Very rare may affect up to 1 in 10 000 people
Not known
Frequency cannot be estimated from the available data

You may experience the following side effects:

Very common:
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
- Sleepiness
- Dizziness
- Nausea (sickness)

Common:
- Urge to behave in an unusual way
- Hallucinations (seeing, hearing or feeling things that are not there)
- Confusion
- Tiredness (fatigue)
- Sleeplessness (insomnia)
- Excess of fluid, usually in the legs (peripheral oedema)
- Headache
- Hypotension (low blood pressure)
- Abnormal dreams
- Constipation
- Visual impairment
- Vomiting (being sick)
- Weight loss including decreased appetite

Inappropriate antidiuretic hormone secretion*
Restlessness
Dyspnoea (difficulties to breathe)
Hiccups
Pneumonia (infection of the lungs)
Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Strong impulse to gamble excessively despite serious personal or family consequences.
Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Uncontrollable excessive shopping or spending
Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
Delirium (decreased awareness, confusion, loss of reality)

Rare:
- Mania (agitation, feeling elated or over-excited)
- Spontaneous penile erection

Not known:
- After stopping or reducing your MIRAPEXIN treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store MIRAPEXIN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.
This medicinal product does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What MIRAPEXIN contains

The active substance is pramipexole.

Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, or 4.5 mg pramipexole dihydrochloride monohydrate, respectively.

The other ingredients are hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.

What MIRAPEXIN looks like and contents of the pack
MIRAPEXIN 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
MIRAPEXIN 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to off-white and of oval shape.

All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P1, P2, P3, P12, P4, P13, or P5 on the other side, representing the tablet strengths 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg, respectively.

All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets). Not all pack sizes may be marketed.